GRAS Adulteration among Industry Hot Topics

While the nutraceuticals industry is poised for great growth, particularly with the crossover of more ingredients into foods and beverages as GRAS ingredients, concerns about adulteration continue to plague the marketplace. Marc Ullman, an industry attorney, spoke with Jon Benninger, Virgo Publishing in October 2010 during SupplySide West on these issues.

In the area of GRAS, Ullman spoke on a panel regarding possible changes to the GRAS affirmation and notification process. However, he told Benninger one of the major new frontiers appears to stem from the update to the FFD&CA in 2007, which may expand the definition of a drug to overlap with that of a new dietary ingredient being researched in advance of market release. He noted the standard of "substantial clinical investigation" is raising questions, even as FDA is adding a caveat into responses to GRAS notifications that this law could potentially position the ingredient as a drug, which could not be added to food.

In his interview, Ullman also discussed the issue of adulteration, a "widespread" problem in the dietary supplement industry, particularly within the weight loss, sexual enhancement and sports nutrition categories. What Ullman sees as potentially stemming the continued problem would be FDA stepping up and bringing criminal casesas it has the power to doagainst firms marketing adulterated products. He said by upping the risk level to a criminal offense, companies might not see the benefit to playing fast and loose in the industry.